Technology & Devices

Medtronic Enters into Definitive Agreement to Acquire Titan Spine

DUBLIN – May 9, 2019 – Medtronic plc (NYSE:MDT), a global leader in medical technology, today announced that it has entered into a definitive agreement pursuant to which it will acquire Titan Spine, a privately-held titanium spine interbody implant and surface technology company. The boards of directors of both companies have …

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Boston Scientific to Acquire Vertiflex, Expanding Portfolio of Interventional Pain Therapies

MARLBOROUGH, Mass., May 9, 2019 /PRNewswire/ — Boston Scientific (NYSE: BSX) today announced that it has entered into a definitive agreement to acquire Vertiflex, Inc., a privately-held company which has developed and commercialized the Superion® Indirect Decompression System, a minimally-invasive device used to improve physical function and reduce pain in …

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Signatera Blood Tests Detects Bladder Cancer Relapse Up to Eight Months Earlier Than Current Clinical Standards

SAN CARLOS, Calif., May 7, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) today announced the publication of a clinical validation study demonstrating that its Signatera™ molecular residual disease (MRD) test was highly prognostic of recurrence in patients with bladder cancer, and it identified recurrence up to 8.2 months earlier than …

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FDA Grants Breakthrough Device Designation to Natera’s Signatera Test

SAN CARLOS, Calif., May 6, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) today announced that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” designation for its Signatera™ test for use in the post-surgical detection and quantification of circulating tumor DNA (ctDNA) in the blood of patients previously …

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Roche Expands Partnership with Bio-Techne to Offer Drug Discovery Researchers New Chromogenic Detection Options for mRNA ISH Tissue Analysis

INDIANAPOLIS, May 6, 2019 /PRNewswire/ — Roche (SIX: RO, ROG;OTCQX: RHHBY) today announced it has expanded its partnership with Bio-Techne by offering drug discovery researchers in the U.S. new chromogenic detection kits for automated in situ hybridization (ISH) tissue analysis. The new Roche kits include the DISCOVERY mRNA Purple HRP …

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FDA Grants Breakthrough Device Designation to Caris Life Sciences’ MI Transcriptome Companion Diagnostic Test

IRVING, Texas, May 3, 2019 /PRNewswire/ — Caris Life Sciences®, a leading innovator in molecular science focused on precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s MI Transcriptome™ companion diagnostic (CDx) test. Designed to detect gene fusions in …

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Presage and Celgene Collaborate to Investigate Novel Agents with CIVO Technology

SEATTLE, May 2, 2019 /PRNewswire/ — Presage Biosciences, a cancer biotechnology company pioneering a new cancer drug development approach using its CIVO™ intratumoral microdosing platform, today announced it has entered into a research collaboration with Celgene Corporation to evaluate several of Celgene’s early stage assets in Phase 0 trials. Presage’s CIVO platform is …

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FDA Grants Breakthrough Device Designation to KidneyIntelX, AI-Enabled Diagnostic for Kidney Disease

NEW YORK, May 2, 2019 /PRNewswire/ — Renalytix AI plc (LON: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such …

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Myriad Announces that EndoPredict Predicts the Chemotherapy Benefit in Women with ER-Positive, HER2-Negative Breast Cancer

SALT LAKE CITY, April 30, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced an international team of cancer researchers has found that EndoPredict® test accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy.  Findings from the study …

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AstraZeneca and BenevolentAI Partner to use Artificial Intelligence and Machine Learning for Development of New CKD and IPF Treatments

AstraZeneca and BenevolentAI today began a long-term collaboration to use artificial intelligence (AI) and machine learning for the discovery and development of new treatments for chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF). Scientists from the two organisations will work side-by-side to combine AstraZeneca’s genomics, chemistry and clinical data …

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